a8946f
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of March
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on Phase III GY004 trial for cediranib
added to Lynparza
in
platinum-sensitive relapsed ovarian
cancer
12 March 2020 07:00 GMT
Update on Phase III GY004 trial for cediranib added to
Lynparza in platinum-sensitive relapsed ovarian
cancer
The trial did not meet the primary endpoint of
progression-
free survival vs. platinum-based chemotherapy
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced
high-level results from the Phase III GY004 trial, led by NRG
Oncology and sponsored by the US National Cancer Institute (NCI),
that examined primarily the efficacy and safety of the potential
new medicine cediranib added to Lynparza (olaparib) versus platinum-based
chemotherapy in patients with platinum-sensitive relapsed ovarian
cancer. Ovarian cancer is the eighth most common cause of death
from cancer in women worldwide.
The trial did not meet the primary endpoint in the intent-to-treat
(ITT) population of a statistically significant improvement in
progression-free survival (PFS) with cediranib added
to Lynparza versus platinum-based chemotherapy.
Cediranib is an oral vascular endothelial growth factor receptor
(VEGFR) inhibitor, which blocks the growth of blood vessels
supporting tumour growth.
José Baselga, Executive Vice President, Oncology R&D,
said: "Despite these disappointing results, we remain committed to
expanding on the benefits already demonstrated
with Lynparza for patients with advanced ovarian cancer.
We will work closely with NRG Oncology and the NCI to review the
full results to inform our ongoing research."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Ovarian cancer is one of the most difficult tumours to
diagnose and treat early. AstraZeneca, MSD and our partners will
continue to explore ways to help patients through our joint
clinical trial development programme."
The safety and tolerability profiles observed in GY004 were
generally consistent with those known for each
medicine.
The NCI and NRG Oncology will present the full data at a
forthcoming medical meeting.
Ovarian cancer
Ovarian
cancer is the eighth most common cause of death from cancer in
women worldwide.1 In 2018, there
were nearly 300,000 new cases diagnosed2 and around
185,000 deaths.1 Most women are
diagnosed with advanced (Stage III or IV) ovarian cancer and have a
five-year survival rate of approximately 30%.3 The primary aim
of treatment in relapsed ovarian cancer is to delay progression of
the disease for as long as possible, therefore increasing the time
to re-initiation of chemotherapy with its associated toxicities,
and maintaining quality of life for these patients.4,5,6
GY004
GY004 is an open-label, randomised, multicentre, Phase III trial
testing the efficacy and safety of the potential new medicine
cediranib added to Lynparza, versus Lynparza monotherapy versus standard platinum-based
chemotherapy in patients with recurrent platinum-sensitive ovarian
cancer, fallopian tube, or primary peritoneal cancer patients, with
or without a BRCA mutation.
The GY004 trial is led by NRG Oncology, a non-profit research
organisation funded by the NCI, in collaboration with AstraZeneca.
The NCI is part of the National Institutes of Health. AstraZeneca
provided both cediranib and Lynparza to support the trial through a Cooperative
Research and Development Agreement with the
NCI.
Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor
and the first targeted treatment to block DNA damage response (DDR)
in cells/tumours harbouring a deficiency in homologous
recombination repair, such as mutations in BRCA1 and/or BRCA2.
Inhibition of PARP with Lynparza leads to the trapping of
PARP bound to DNA single-strand breaks, stalling of replication
forks, their collapse and the generation of DNA double-strand
breaks and cancer cell death. Lynparza is being tested in a
range of PARP-dependent tumour types with defects and dependencies
in the DDR pathway.
Lynparza is currently approved in 73 countries,
including those in the EU, for the maintenance treatment of
platinum-sensitive relapsed ovarian cancer. It is approved in the
US, the EU, Japan, China and several other countries as 1st-line
maintenance treatment of BRCA-mutated advanced ovarian cancer
following response to platinum-based chemotherapy. It is also
approved in 58 countries, including the US and Japan, for germline
BRCA-mutated, HER2-negative, metastatic breast cancer, previously
treated with chemotherapy; in the EU, this includes locally
advanced breast cancer. In 2019, Lynparza was additionally approved
in the US for the treatment of germline BRCA-mutated metastatic
pancreatic cancer. Regulatory reviews are underway in other
jurisdictions for ovarian, breast, pancreatic and prostate
cancers.
Lynparza, which is being jointly developed and
commercialised by AstraZeneca and MSD, is approved for the
treatment of advanced ovarian cancer, metastatic breast cancer and
pancreatic cancer. It has been used to treat over 30,000 patients
worldwide. Lynparza has the broadest and most
advanced clinical-trial development programme of any PARP
inhibitor, and AstraZeneca and MSD are working together to
understand how it may affect multiple PARP-dependent tumours as a
monotherapy and in combination across multiple cancer
types. Lynparza is the foundation of
AstraZeneca's industry-leading portfolio of potential new medicines
targeting DDR mechanisms in cancer cells.
Cediranib
Cediranib
is an oral vascular endothelial growth factor (VEGF) receptor
inhibitor that has demonstrated efficacy as a monotherapy and in
combination in various cancers. Cediranib has shown anti-tumour
activity in many cancers, including ovarian, breast, colorectal,
renal, lung, sarcoma and glioblastoma. Cediranib is being evaluated
in combination with Lynparza in advanced ovarian
cancer in the Phase II CONCERTO trial, Phase II/III GY005 trial
(sponsored by the NCI) and Phase III ICON9 trial (sponsored by
University College, London).
The AstraZeneca and MSD strategic oncology
collaboration
In July
2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the US and Canada, announced a global
strategic oncology collaboration to co-develop and
co-commercialise Lynparza, the world's first PARP
inhibitor, and potential new medicine selumetinib, a MEK inhibitor,
for multiple cancer types. Working together, the companies will
develop Lynparza and selumetinib in
combination with other potential new medicines and as
monotherapies. Independently, the companies will
develop Lynparza and selumetinib in
combination with their respective PD-L1 and PD-1
medicines.
AstraZeneca in oncology
AstraZeneca
has a deep-rooted heritage in oncology and offers a quickly growing
portfolio of new medicines that has the potential to transform
patients' lives and the Company's future. With six new medicines
launched between 2014 and 2020, and a broad pipeline of small
molecules and biologics in development, the Company is committed to
advance oncology as a key growth driver for AstraZeneca focused on
lung, ovarian, breast and blood cancers. In addition to
AstraZeneca's main capabilities, the Company is actively pursuing
innovative partnerships and investment that accelerate the delivery
of our strategy, as illustrated by the investment in Acerta Pharma
in haematology.
By
harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and, one day, eliminate cancer as a cause
of death.
AstraZeneca
AstraZeneca
(LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three therapy areas - Oncology,
Cardiovascular, Renal and Metabolism, and Respiratory. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Media Relations
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Viña
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Rob
Skelding
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Oncology
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+44 203 749 5821
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Rebecca
Einhorn
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Kent
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Fiorin
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References
1. The World Health Organization. IARC. Globocan 2018. Estimated
number of deaths in 2018. http://gco.iarc.fr/ [Accessed
March 2020].
2. The World Health Organization. IARC. Globocan 2018. Estimated
number of new cases in 2018. http://gco.iarc.fr/ [Accessed
March 2020].
3. National Cancer Institute. (2019). Cancer Stat Facts: Ovarian
Cancer Available at: https://seer.cancer.gov/statfacts/html/ovary.html [Accessed
March 2020].
4. Gupta
et al. (2019). Maintenance therapy for recurrent epithelial ovarian
cancer: current therapies and future perspectives - a
review. Journal of Ovarian
Research. 12, 103
(2019). https://doi.org/10.1186/s13048-019-0579-0
5.
DiSilvestro et al. (2018). Maintenance treatment of recurrent
ovarian cancer: Is it ready for prime time?. Cancer Treatment Reviews, 69,
pp.53-65.
6. American Cancer Society. (2019). Understanding Maintenance
Therapy. Available at: www.cancer.net/navigating-cancer-care/how-cancer-treated/understanding-maintenance-therapy [Accessed
March 2020].
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
12 March
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|